# EUR-Lex - 52013DC0135 - EN

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# 52013DC0135

**COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics /* COM/2013/0135 final */**

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TABLE OF CONTENTS

1........... Introduction.................................................................................................................... 3

2........... The 2013 marketing ban................................................................................................. 3

2.1........ The legal framework....................................................................................................... 3

2.2........ Availability of alternative
methods.................................................................................... 4

2.3........ Assessing the impacts of the 2013
marketing ban............................................................. 5

2.4........ Deciding on the way forward.......................................................................................... 5

3........... The way forward............................................................................................................ 7

3.1........ Implementing the 2013 marketing
ban and monitoring its effects....................................... 7

3.2........ Commitment to support research,
development and validation of alternative methods to assess human safety    9

3.3........ Alternative methods as a
prominent part of the Union's trade and international agenda.... 11

4........... Conclusions.................................................................................................................. 13

Annex......................................................................................................................................... 14

COMMUNICATION FROM THE COMMISSION TO
THE EUROPEAN PARLIAMENT AND THE COUNCIL

on the animal
testing and marketing ban and on the state of play in relation to alternative
methods in the field of cosmetics

(Text with EEA relevance)

1.           Introduction

This Communication has a twofold purpose:

–
It informs the European Parliament and the
Council of the Commission's decision not to propose any changes in the animal
testing related provisions in Directive 76/768/EEC (Cosmetics Directive)[1] and in Regulation 1223/2009/EC
(Cosmetics Regulation)[2],
the reasons why and the way forward.

–
It presents the yearly report in accordance with
Article 9 of the Cosmetics Directive and as such the tenth Commission report on
the development, validation and legal acceptance of alternative methods to
animal tests in the field of cosmetics.

2.           The
2013 Marketing Ban

2.1.        The
legal framework

The Cosmetics Directive foresees a phasing-out
of animal testing for cosmetic products. Animal testing of finished cosmetic
products in the Union has been prohibited since 2004 and of cosmetic ingredients
since March 2009 ("testing ban"). As from 11 March 2009, it is also
prohibited to market in the Union cosmetic products and their ingredients which
have been tested on animals in order to meet the requirements of the Directive
("2009 marketing ban"). This marketing ban applies to all but the
most complex human health effects ("endpoints") to be tested to
demonstrate the safety of cosmetic products (repeated-dose systemic toxicity,
skin sensitisation, carcinogenicity, reproductive toxicity and toxicokinetics),
for which the European Parliament and the Council extended the deadline to 11
March 2013 ("2013 marketing ban"). The Cosmetics Regulation, which
repeals and replaces the Cosmetics Directive as of 11 July 2013, contains the
same provisions. Data from animal testing that has been carried out before the
respective implementation dates of the marketing ban (11 March 2009/11 March
2013) can continue to be relied on in the safety assessment of cosmetic
products.

The testing and marketing bans in the Cosmetics
Directive/Regulation apply even in case alternative methods to animal testing are
not yet available. This reflects a sector-specific political choice by the
European Parliament and the Council. Other Union legislation recognises that
animal testing is still needed in the absence of alternative methods to ensure
the protection of human health and the environment, but sets very high animal
welfare standards for such testing and requires that whenever possible testing
is replaced, reduced and refined.

According to Article 4a (2.3) of the Cosmetics
Directive the Commission was called upon to inform the European Parliament and
the Council where, for technical reasons, one or more of the tests covered by
the 2013 marketing ban would not be developed and validated by 2013 and to put
forward a legislative proposal. The Commission has responded to this provision
in two steps.

2.2.        Availability
of alternative methods

The first step was to establish to which extent
alternative methods for testing cosmetic products and their ingredients for the
relevant endpoints are available by 2013. The Commission has provided a report
to the European Parliament and the Council on the availability of alternative
methods in September 2011[3],
based on a comprehensive technical report which was the result of wide
scientific input and a public consultation[4].
The basic findings of this technical report are still valid and the full
replacement of the 2013 marketing ban endpoints by alternative methods remains
not yet possible.

Considerable progress has been made in recent
years. Much of this is due to the sustained efforts of the European Union
Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), run by
the Commission's Joint Research Centre (JRC). For the endpoints falling under
the 2009 marketing ban, replacement methods have been successfully validated
and adopted as OECD test guidelines in the fields of skin irritation and
corrosion, phototoxicity and skin penetration. Partial replacement methods
suitable for inclusion in testing strategies have been validated in the areas
of acute systemic toxicity and eye irritation, and adopted as OECD test guidelines
in the field of eye irritation. Refinement of the established in vitro
genotoxicity tests and testing strategies will contribute to addressing this
endpoint. For the 2013 marketing ban endpoints, ECVAM successfully validated
test methods in the fields of skin sensitisation and carcinogenicity which are
now being discussed at the OECD.

A summary of recent validation activities at
ECVAM and advancement concerning regulatory acceptance is provided in Tables 1 and 2 in the Annex. This update covers the period from
2010 to present day. Summaries covering periods prior to 2010 are covered in
the ECVAM technical report 2008-2009[5].

For the outstanding complex endpoints
replacement will not be achieved by replacing one animal test with one in
vitro test. Replacement can only be achieved through integrated testing
strategies, combining several in vitro and in silico approaches.
For example, none of the methods under validation for skin sensitisation and
referenced in the Annex will replace skin sensitisation testing as a
stand-alone method, they constitute mosaic pieces needed for a comprehensive
testing strategy.

A more comprehensive description of progress being
made in the development, validation and regulatory acceptance of alternative
methods in the different toxicological areas will be provided in the ECVAM
technical report 2013, which will become available in
parallel with this Communication[6].

The responsible scientific committee of the
Commission, the Scientific Committee on Consumer Safety (SCCS), has recently
adopted an updated version of its "Notes of Guidance"[7], in which it also provides an
overview of the use of alternative methods in the safety assessment of
cosmetics. Specific guidance was also adopted by the SCCS in relation to the
safety assessment of nanomaterials in cosmetics[8],
including availability of alternative methods.

2.3.        Assessing
the impacts of the 2013 marketing ban

The second step was to carry out an impact
assessment and an in-depth reflection on the best way forward in relation to
the 2013 marketing ban in light of the unavailability of a full set of
alternative methods. The resulting impact assessment is published as a
Commission Staff Working document accompanying this Communication[9].

The options assessed in the impact assessment were
to maintain the 2013 marketing ban, to postpone it or to introduce a derogation
mechanism. The derogation mechanism would have allowed manufacturers to request
the Commission to grant individual derogations from the 2013 marketing ban for
innovative ingredients with a significant added value to consumer health,
well-being and/or the environment.

The impact assessment shows that the 2013 marketing
ban could lead to a reduced access to cosmetic ingredients. However,
stakeholder views on the effects diverge. Despite serious efforts to establish a
solid body of data, considerable uncertainty remains in relation to the
quantification of these impacts; it appears possible to at least mitigate them
through appropriate action. Even for the 2009 marketing ban deadline, not all
testing endpoints can be fully replaced by alternative methods which did not
lead to major negative impacts so far.

The objective to provide a high level of human
health, key to the Cosmetics Directive and reinforced in the Cosmetics Regulation,
is not impacted by the 2013 marketing ban. If product safety cannot be
demonstrated the product simply cannot be placed on the market. New tools are
provided in the Cosmetics Regulation to ensure this, such as enhanced market
surveillance and new rules on communication of serious undesirable effects.

2.4.        Deciding
on the way forward

In light of this impact assessment, the
Commission has come to the conclusion that it is most appropriate to let the 2013
marketing ban enter into force and not to present a legal proposal to either
postpone the deadline or provide for individual derogations for the following
reasons:

First, the Commission considers that further
postponements of the 2013 marketing ban would not reflect the political choices
of the European Parliament and the Council when adopting the respective
provision. Animal welfare considerations were at the origin when the first
provisions on a marketing ban of cosmetics tested on animals were introduced 20
years ago[10]. The marketing ban, first introduced in 1993
with a deadline for 1998, was introduced with the clear political objective to
end animal testing for cosmetics without being based on a scientific estimation
when a full set of alternative methods would be available. Similarly, the
European Parliament and the Council imposed the testing ban and the 2009 marketing
ban in full knowledge that by that time a complete replacement of the relevant
animal tests would not be possible. The European Parliament and the Council did
not make the 2013 marketing ban dependent on the availability of a full set of replacement
methods. In the meantime animal welfare has been enshrined in Article 13 of the
Treaty on the Functioning of the European Union (TFEU) as a European value to
be taken into account in Union policies.

Secondly, any change to the 2013 marketing ban
could seriously diminish determination to swiftly develop alternative test
methods. Past experience demonstrates clearly that animal testing provisions in
the cosmetics legislation have been a key accelerator in relation to the
development of alternative methods and have sent a strong signal far beyond the
cosmetics sector and far beyond Europe. Methods developed in the cosmetics
sector, such as reconstructed human skin models, are now used in other sectors
as well and the interest in alternative methods for cosmetics has grown in many
countries outside the Union. The animal testing provisions motivated the
creation of the European Partnership on Alternative Approaches to Animal
Testing (EPAA)[11],
an unprecedented voluntary collaboration between the European Commission,
European trade associations, and companies from various industry sectors. The
provisions equally contributed to a great increase of the number of validated
methods since 2003 when the current deadlines were set[12].

Thirdly, a case-by-case derogation allowing the
Commission to deviate from the 2013 marketing ban for individual ingredients
offering significant benefits for the consumer or the environment would benefit
mainly larger manufacturers capable of gathering the necessary evidence. In
addition, it would raise controversial decisions by the Commission on what is a
significant benefit, a decision for which objective criteria are difficult to
establish.

Finally, the Commission considers that the
possible risks from the 2013 marketing ban can be turned into an opportunity
for the Union to set an example of responsible innovation in cosmetics with
positive impact beyond Europe. The need for a new risk assessment paradigm from
a scientific perspective is by now widely recognized[13]. Impacts go beyond the
cosmetics sector – the objective is to develop strategies that will lead to
better and more predictive, faster and cheaper tools to assess consumer safety
of chemical substances.

Fully reaping the potential of alternative
methods is a challenging endeavour that will require a shift in thinking of all
involved. The cosmetics sector can - once again - act as an accelerator and a
pioneer in the development of these novel approaches. Considering however that a
full safety assessment for cosmetics only relying on alternative methods and
approaches is not yet achieved and in some respects is not even close, it is
necessary to set the appropriate framework by:

·
Implementing the 2013 marketing ban while carefully
monitoring its effects;

·
Continuing to support research, development and
validation of alternative methods to assess human safety; and

·
Making alternative methods part of the Union's trade and international agenda.

3.           The
Way Forward

3.1.        Implementing
the 2013 marketing ban and monitoring its effects

Effective and coherent implementation and
enforcement of the 2013 marketing ban are of key importance – not only to
ensure that it actually achieves its objectives, but also to ensure a level
playing field for economic operators. This Communication focuses on the 2013
marketing ban. However, the described implementation mechanisms and principles apply
equally to the testing ban and the 2009 marketing ban.

Going forward the Cosmetics Regulation provides
the adequate legal framework to ensure the implementation of the 2013 marketing
ban and its provisions are directly applicable in all Member States as of 11
July 2013. It is accordingly the task and responsibility of the Member State authorities to monitor compliance with the Cosmetics Regulation via in-market
controls of the cosmetic products made available on the market[14]. The Cosmetics Regulation lays
down the obligation of the responsible person[15]
to ensure compliance with the animal testing provisions[16]. It requires Competent
Authorities to take all appropriate measures to ensure compliance with the animal
testing provisions[17]
and requires Member States to have effective, proportionate and dissuasive
penalties in place in case of infringements[18].
Until 11 July 2013 the existing implementation mechanisms under the Cosmetics
Directive will continue to apply[19].

The main source enabling Member State
authorities to verify compliance with the 2013 marketing ban is the product information
file in accordance with Article 7a (1) h of the Cosmetics Directive/Article 11
of the Cosmetics Regulation. This file must contain data on "any animal
testing performed by the manufacturer, his agents or suppliers, relating to the
development or safety assessment of the cosmetic product or its ingredients,
including any animal testing performed to meet the legislative or regulatory
requirements of third countries". In addition to this requirement, the
product information file must also contain the cosmetic product safety report
as specified in Annex I of the Cosmetics Regulation, which must include
information on the toxicological profile of the substance for all relevant
toxicological endpoints and a clear identification of the source of the
information. From this information it will become evident to Competent
Authorities if animal testing data has been relied on in the safety assessment.

Currently, there is no jurisprudence of the
Court of Justice of the European Union ('the Court') on the interpretation of
the scope of the 2013 marketing ban. The Commission recalls that only the Court
can provide a legally binding interpretation of Union law. The Commission will,
under the control of the Court oversee the application of the 2013 marketing
ban. The Commission will do so in accordance with its current understanding of
the scope of the 2013 marketing ban, which is based on the Cosmetics
Regulation/Directive and which does not create any new rights and obligations.
The practical application of the 2013 marketing ban will remain a case-by-case
decision of the respective Member State authority. Under the Cosmetics
Directive and its national transpositions Member States already oversee
compliance with the testing ban and the 2009 marketing ban. The Commission has
reported in its last two Annual Reports on the measures taken by Member States
to ensure compliance with these bans.[20]

The majority of ingredients used in cosmetic
products are ingredients that are equally in use in many other consumer and
industrial products, such as in pharmaceuticals, detergents and food, and
animal testing may be necessary to ensure compliance with the legal frameworks
applicable to these products. Ingredients used in cosmetics will generally also
be subject to the horizontal REACH[21]
requirements and animal testing may be necessary as a last resort to complete
the respective data packages. It therefore is for Member States to assess and
decide whether such testing for compliance with other frameworks is considered
to be falling in the scope of the 2013 marketing ban. Critical to this is the
wording 'in order to meet the requirements of this Directive/Regulation'
used in the Cosmetics Directive and the Cosmetics Regulation[22] in order to qualify the scope
of the 2013 marketing ban.

The Commission considers that animal testing
that has clearly been motivated by compliance with non-cosmetics related legislative
frameworks should not be considered to have been carried out 'in order to
meet the requirements of this Directive/Regulation'. The resulting animal
testing data should not trigger the marketing ban and could subsequently be
relied on in the cosmetics safety assessment. Reliance on such data is subject
to its relevance for the cosmetics safety assessment and its compliance with
data quality requirements[23].

Testing carried out for cosmetics relevant
endpoints on ingredients that have been specifically developed for cosmetic
purposes and are exclusively used in cosmetic products would in the
Commission's view always be assumed to be carried out 'in order to meet the
requirements of this Directive/Regulation'.

The Commission considers that the marketing ban
is triggered by the reliance on the animal data for the safety assessment under
the Cosmetics Directive/Regulation, not by the testing as such. In case animal testing
was carried out for compliance with cosmetics requirements in third countries, this
data cannot be relied on in the Union for the safety assessment of cosmetics.

In the context of the obligation to ensure
compliance with the Cosmetics Directive/Regulation, Member States should ensure
that the appropriate and effective mechanisms are put into place in order to
counter the potential risks of abuse in the application of the testing and the
marketing ban. Where needed, the Commission will work with Member States on
guidance for the application of the 2013 marketing ban based on practical
experiences and concrete case studies. The Platform of European Market
Surveillance Authorities for Cosmetics (PEMSAC) provides a dedicated structure
for cooperation on market surveillance.

In order to allow effective market
surveillance, responsible persons should ensure that for any animal testing
data relied on in the product information file the date and place of the test
is clearly documented. If testing took place after the 2013 marketing ban deadline,
the product information file should allow verification on whether the testing
was carried out in order to meet the requirements of the Directive/Regulation
or for other purposes. To this end the file should contain documentation on any
use of the substance in products other than cosmetic products (product
examples, market data etc.), as well as documentation on compliance with other
regulatory frameworks (e.g. REACH or other legal frameworks) and a justification
of the need for the animal testing under that other framework (e.g. testing
proposal under REACH).

The 2013 marketing ban applies to all cosmetic
products placed on the Union's market, thus to those produced in the Union and to imported cosmetic products alike. Competent authorities should ensure a level
playing field between the different products on the market.

Considering that the non-availability of
alternative test methods could have an impact on the innovation in cosmetic
ingredients and products and the competitiveness of the sector, the Commission
will closely monitor the situation in the coming years. A key tool for the
monitoring will be the yearly Commission reports required under Article 35 of
the Cosmetics Regulation. These reports give a regular review of the state of
play of the development, validation and regulatory acceptance of alternative
methods in the field of cosmetics. They will, as has been the case in the past,
be based on technical reports prepared by the Commission's JRC (EURL ECVAM). Given
that the testing bans are fully applicable, the reports will no longer contain
statistical data on the number and type of animal experiments carried out
relating to cosmetic products in the Union. The reports will cover any
derogations granted in accordance with Article 4a (2.4) of the Cosmetics
Directive and Article 18 (2) of the Cosmetics Regulation. These provisions
allow Member States to request a derogation in case a human health problem is
substantiated for an ingredient that is in wide use and cannot be replaced by
another ingredient capable of performing a similar function. So far only one
such request has been received and the analysis is still on-going.

In addition, the Commission will monitor
instances in which a conclusive safety assessment is not feasible as a result
of the 2013 marketing ban. The Commission will equally monitor the
socio-economic impacts of the 2013 marketing ban, notably in comparison to the
data cited in the Impact Assessment and the estimates and predictions made in
that context.

3.2.        Commitment
to support research, development and validation of alternative methods to assess human safety

The Union wishes to set an example of
responsible innovation in cosmetics without new dedicated animal tests. It is therefore
crucial to continuously support the research and development of methods to better
assess human safety and capitalize on past efforts by ensuring that the latest
scientific advances are translated into animal-free solutions.

The Commission has made about EUR 238 million
available between the years 2007 and 2011 for research into alternative methods
to animal testing alone. The major part of this budget, around EUR 198 million,
was spent on projects funded through the 6th and 7th Framework Programmes and
the LIFE+ Programme. The second most important tranche, about EUR 38 million,
was committed through the institutional budget of the JRC, in particular to
support the activities of its Institute for Health and Consumer Protection in
the alternatives area including the operation of the European Reference
Laboratory for Alternative Methods to Animal Testing (EURL ECVAM).

The SEURAT-1[24]
initiative ('Safety Evaluation Ultimately Replacing Animal Testing') is unique
in that it is a jointly funded initiative by the European Commission and the
cosmetics industry, each of which are contributing EUR 25 million between 2011
and 2015. It is proof of the active role assumed by the cosmetics industry in
the development of alternative testing methods. SEURAT-1 brings together more
than 70 European research teams working together within a cluster of six
complementary projects and facilitated by a coordination action. The goal of
the 5-year SEURAT-1 programme is to use knowledge of toxicological processes to
develop and rationally assemble novel technology building blocks required for predicting
repeated dose systemic toxicity in humans potentially caused by exposure to
chemicals. Ultimately SEURAT-1 aims to prove key concepts underpinning the
credible use of combinations of computational and in vitro methods for
supporting safety assessment decisions.

The research into alternative methods is by no
means near an end: in many areas the research currently underway is only a
first step. Horizon 2020[25]
is the financial instrument which implements the Innovation Union[26] and will ensure the framework
for the research activities between 2014 and 2020. Horizon 2020 offers the
opportunity to continue and expand the Union's commitment to research in
alternative, better methods of human safety assessment and capitalize on possible
innovation in this field.

The Commission recognizes the importance of
research in this field. At the same time, strong commitment is required from
the sectors that would benefit from the development of new alternative methods,
including the cosmetics sector.

The Commission will engage with stakeholders from
such sectors to define the research priorities going ahead and the best implementation
instruments which, for example, could take the form of a new public-private
partnership. A recent Discussion Paper of the Scientific Committees on
“Addressing the New Challenges for Risk Assessment” points to research needs
for comprehensive open access databases, in silico methods, (toxicological)
mode-of-action studies and exposure assessment tools. The EPAA can also play a
role in defining research needs and priorities across industry sectors with special
attention being paid to how to involve small and medium sized enterprises in
these efforts.

A crucial factor for success is to make sure
that alternative methods, once developed, are rapidly made available for end-users
to generate toxicological information acceptable to regulators. The Commission
therefore commits to work with the relevant European and international bodies
to further improve the validation process for new test methods.

Validation is an intrinsic part of the
scientific process and of fundamental importance in gaining acceptance of
alternative methods and trust in the information they generate. In recent years
JRC's EURL ECVAM has further refined and streamlined its validation processes
and has increased the resources it commits to the alternatives area including
dedicating the efforts of more than 50 scientific and technical staff. ECVAM is
now expressively referenced in Directive 2010/63/EU[27] and its responsibilities are
clearly spelled out. In addition to undertaking validation studies, ECVAM will also
play a stronger role in guiding the development of alternatives and in early
and frequent engagement with regulators and stakeholders to ensure that
priority is given to the most relevant methods that will have the greatest
impact. To this end, ECVAM has also established its regulatory advisory body[28] and its stakeholder forum[29].

The ECVAM Scientific Advisory Committee will
continue to offer impartial expert advice, particularly during its peer review
of validation studies, while ECVAM Recommendations will be the key instrument
for communicating the outcome of validation studies and additional advice on
how an alternative method should be utilised to most effect. ECVAM will also
carry on its active dissemination of comprehensive information on available
methods to end-users through ECVAM's publicly accessible Data Base service on
Alternative Methods[30]
and the ECVAM Search Guide.

Commission Regulation (EC) 440/2008[31] brings together all regulatory
accepted test methods on Union level. An overview of how methods are
progressing through the acceptance process is available through the Tracking
System for Alternative test methods Review, Validation and Approval in the
Context of Union Regulations on Chemicals[32].
It is important to note that although suitable for the safety assessment of
cosmetics, the alternative methods validated and accepted so far are not solely
applicable to cosmetic ingredients but can successfully be used for other
purposes. Thus Annex IX of the Cosmetics Directive[33] has not been amended and does
not list any specific alternative methods.

3.3.        Alternative
methods as part of the Union's trade and international agenda

There are compelling reasons for a strong
international cooperation on the development of alternative test methods for
cosmetics. Cosmetic products and their ingredients are traded worldwide and the
 Union is home to some of the world-leading brands in the cosmetics field. A
common understanding of the safety assessment for cosmetics and acceptance of
alternative methods will improve human safety, help animal welfare and trade,
but cooperation is also a must because the underlying scientific challenges are
far too big to be shouldered by one region alone. Cooperation at the research
level is therefore a first important step.

A key instrument in agreeing on tools for
safety assessment is the development of OECD Test Guidelines in the framework
of the Existing Chemicals Programme and the Mutual Acceptance of Data. Alternative
methods have been included in OECD Test Guidelines and this has been key in
leading to their international acceptance. The Commission services are actively
involved in the OECD work. One particular challenge to be addressed if
significant progress is to be made is how to reflect Integrated Testing
Strategies in OECD Guidelines, since the information required to address the
more complex health-effect endpoints will require the optimum combination of
both testing and non-test alternative methods.

In the field of cosmetics, the International
Collaboration on Cosmetics Regulation (ICCR) provides an important forum for cooperation
between the United States of America, Canada, Japan and Europe. Alternatives to
animal testing have been a key focus since the inception of ICCR. ICCR has
recently started work on in silico (computational) prediction models, something
that in addition to in vitro methods is of central importance in
advancing alternative safety assessment approaches. ICCR has also started
reaching out beyond its membership, to countries such as Australia, Brazil and the People’s Republic of China.

One of ICCR's key achievements in relation to
alternative methods is clearly the setting up of the International Cooperation
on Alternative Test Methods in 2009. It brings together validation bodies of Europe,
the United States, Japan and Canada. The South Korean validation body joined in
2010. The objective is to promote and harmonise the validation of
alternative methods worldwide, to avoid duplication of effort and to ensure
that recommendations on validated methods are mutually acceptable and can
be directly used in different jurisdictions. Importantly too it works
towards establishing common positions on validated methods between member
countries and organisations of the OECD to accelerate their international
acceptance.

EPAA concentrated its activities in 2012 on
international cooperation and will continue to do so in 2013, offering another
opportunity to promote alternatives internationally. The cosmetics industry
(Cosmetics Europe[34]
and several companies) is one of the driving forces and has in 2012 been joined
by the Fragrances and Flavours industry (IFRA).

The Commission is convinced that the overall
long-term objective to replace animal testing wherever possible and to move to
new ways of improved safety assessment will eventually be shared by many of the
Union ́s trading partners, even though different regions may be at different
steps of the process and the approaches to achieve the objective may differ. In
the last weeks, there have been encouraging signals that other countries such
as Israel or India are considering to follow the Union's example on animal
tests for cosmetics.

The Commission is therefore convinced that the
issue of alternative test methods for cosmetics merits a prominent place on the
EU's trade and international cooperation agenda. It will endeavour to put these
issues on the agenda of all relevant multi and bilateral meetings in the
cosmetics field in 2013, notably with the United States and China, but also in contacts with Brazil and India. The Commission will in this effort look for
synergies with the international initiatives of industry and animal welfare
organisations.

4.           Conclusions

The deadline for the 2013 marketing ban in the
Cosmetics Directive/Regulation enters into force on 11 March 2013. This
completes a 20 year long process on phasing out animal testing for the purpose
of cosmetic safety assessment. Promising progress has been made in advancing
alternative methods to animal testing over the last years, but full replacement
is not yet possible and will not be possible for some time. The Commission
nevertheless believes that the most appropriate way forward is to let the
marketing ban enter into force and to turn the challenges that the 2013
marketing ban is posing into an opportunity, in particular by

- ensuring a coherent implementation of the 2013
marketing ban and monitoring its impacts;

- continuing the support for research,
development and validation of new alternative methods for human safety testing;
and

- making alternative methods an integral part
of the Union's trade agenda and international cooperation.

The marketing ban gives an important signal,
not only in relation to the value attached to animal welfare in the European
Union, but also in relation to the overall paradigm shift in relation to human
safety assessment.

Annex

Table 1. Status of validation of in vitro test methods at EURL ECVAM since 2010

Nr. || Toxicity area || Test method description || Validation status[35]

1 || Carcinogenicity || Cell Transformation Assay (CTA) SHE || EURL ECVAM recommendation published in 2011

2 || || Cell Transformation Assay (CTA) Balb/C || EURL ECVAM recommendation published in 2011

3 || || Cell Transformation Assay (CTA) BHAS || ESAC peer review finalised

4 || Skin sensitisation || Keratinosens test method || ESAC peer review finalised

5 || || Direct Peptide Reactivity Assay (DPRA) || ESAC peer review finalised

6 || || human Cell line Activation Test (h-CLAT) || ESAC peer review foreseen to start in 2013

7 || Acute oral toxicity || 3T3 Neutral Red Uptake (NRU) test method || EURL ECVAM draft recommendation underwent public commenting in 2012

8 || Toxicokinetics || Cytochrome P450 (CYP) induction assay using the human cryopreserved HepaRG® cell line and cryopreserved human hepatocytes || ESAC peer review foreseen to start in 2013

9 || Eye irritation || Reconstructed human tissue model (EpiOcularTM EIT) || ESAC peer review foreseen to start in 2013

10 || || Reconstructed human tissue model (SkinEthicTM HCE) || ESAC peer review foreseen to start in 2013

11 || Endocrine disruption || MELN® estrogen receptor transactivation assay (agonist and antagonist protocols) || ESAC peer review foreseen to start in 2013

12 || || Androgen receptor transactivation assay (agonist and antagonist protocols) || EURL ECVAM validation foreseen to start in 2013

13 || || Androgen receptor transactivation assay (agonist and antagonist protocols) || EURL ECVAM validation foreseen to start in 2013

Table 2. Status of regulatory acceptance of in vitro test methods since 2010

Nr. || Toxicity area || Test method description || Acceptance status

1 || Skin corrosion || Recontructed human Epidermis test methods (RhE) as included in OECD TG[36] 431/EU TM[37] B.40 bis || Accepted in 2004, updated version (sub-categorisation, performance standards, inclusion of SkinEthicTM RHE and epiCS®) will be discussed at WNT[38] in 2013

2 || || Transcutaneous electrical resistance (TER) test as included in OECD TG 430/EU TM B.40 || Accepted in 2004, updated version (performance standards) will be discussed at WNT in 2013

3 || Skin irritation || Recontructed human Epidermis test methods (RhE) as included in OECD TG 439/EU B.46 || Accepted in 2010, updated version (performance standards, inclusion of LabCyte EPI-model) will be discussed at WNT in 2013

4 || Eye irritation || Fluorescein Leakage (FL) test method as included in OECD TG 460 || Accepted in 2012

5 || || Bovine Corneal Opacity and Permeability (BCOP) test method as included in OECD TG 437/EU TM B.47 || Accepted in 2009, updated version (positive control, use in a bottom-up approach to identify non-classified chemicals) will be discussed at WNT in 2013

6 || || Isolated Chicken Eye (ICE) test method as included in OECD TG 438/EU TM B.48 || Accepted in 2009, updated version (use in a bottom-up approach to identify non-classified chemicals) will be discussed at WNT in 2013

7 || || Cytosensor Microphysiometer (CM) test method || New draft TG will be discussed at WNT in 2013

8 || Carcinogenicity || Cell Transformation Assay (CTA) SHE || New draft TG will be discussed at WNT in 2013

9 || Genotoxicity || Existing OECD TGs under revision || Draft OECD TG 473 (in vitro chromosome aberration assay) and OECD TG 487 (in vitro micronucleus test) will be discussed at WNT in 2013

10 || Endocrine disruption || Estrogen receptor transactivation assay (BG1Luc ER TA; agonist and antagonist protocols) as included in OECD TG 457 || Accepted in 2012

11 || || Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists (OECD TG 455) || Accepted in 2012

[1]               Council Directive of 27 July 1976 on the
approximation of the laws of the Member States relating to cosmetic products,
OJ L 262, 27.9.1976, p. 169.

[2]               Regulation 1223/2009/EC of the European Parliament
and of the Council of 30 November 2009 on cosmetic products, OJ L 342, 22.12.2009,
p. 59.

[3]               Report on the Development, Validation and Legal
Acceptance of Alternative Methods to

Animal Tests
in the Field of Cosmetics (2009), 13.9.2011, COM(2011) 558 final.

[4]               "Alternative (non-animal) methods for cosmetics
testing: current status and future prospects—2010", see:http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/final_report_at_en.pdf

[5]               Zuang
et al., 2010 ,see: http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/at_ecvam_2008-2009_en.pdf

[6]               See: http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm

[7]               The SCCS'S Notes of Guidance for the testing of
cosmetic substances and their safety evaluation, 8th Revision, SCCS/1501/12,

see: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_006.pdf

[8]               Guidance on the Safety Assessment of Nanomaterials in
Cosmetics, SCCS/1484/12,

see: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_005.pdf

[9]               See http://ec.europa.eu/consumers/sectors/cosmetics/animal-testing/index_en.htm

[10]             Directive 93/35/EEC, OJ L 151, 23.06.1993, p. 0032.

[11]             See: http://ec.europa.eu/enterprise/epaa/

[12]             Between 2003 and 2009 there were 13 new methods,
compared to only 6 between 1998 and 2002.

[13]             See recent Discussion Paper of the Scientific
Committees "Addressing the New Challenges for Risk Assessment"( http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_037.pdf

[14]             Article 22 of Regulation 1223/2009/EC.

[15]             As defined in Article 4 of Regulation 1223/2009/EC.

[16]             Article 5 (1) of Regulation 1223/2009/EC.

[17]             Article 25 (1) (g) and Article 25 (5) of Regulation
1223/2009/EC.

[18]             Article 37 of Regulation 1223/2009/EC.

[19]             Article 3 of Directive 76/768/EEC.

[20]             See: http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/annual_report2009.pdf
and http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/at_report_2008.pdf

[21]             Regulation (EC) No 1907/2006 of the European Parliament
and of the Council of 18 December 2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), establishing a European
Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as
Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC, Official Journal L 136, 29.5.2007, p. 3.

[22]             See Article 4a (1(b)) of the Cosmetics Directive and
Article 18 paragraph 1 (b) of the Cosmetics Regulation.

[23]             Article 7a (2) Directive 76/768/EEC and Article 10 (3)
of Regulation 1223/2009/EC

[24]             See http://www.seurat-1.eu

[25]             Proposal for a Regulation of the European Parliament
and of the Council establishing Horizon 2020 - The Framework Programme for
Research and Innovation (2014-2020), COM(2011) 809 final.

[26]             Communication from the Commission, Europe 2020 Flagship
Initiative, Innovation Union, COM (2010) 546 final.

[27]             Directive 2010/63/EU on the protection of animals used
for scientific purposes, OJ L 276, 20.10.2010, p.33.

[28]             PARERE (Preliminary Assessment of Regulatory Relevance)

[29]             ESTAF (ECVAM Stakeholder Forum)

[30]             http://ecvam-dbalm.jrc.ec.europa.eu/

[31]             See Article 10 (3) of Regulation (EC) 1223/2009 of the
European Parliament and the Council on cosmetics products, 22.12.2009, OJ L
342, p. 59 – 209.

[32]             See http://tsar.jrc.ec.europa.eu/

[33]             Equivalent to Annex VIII in the Cosmetics Regulation,
both list validated alternative methods which are not listed in Commission
Regulation (EC) 440/2008.

[34]             Cosmetics Europe is the Trade Association representing
the European cosmetics industry.

[35]             'Validation Status' refers to the different steps of
the validation process.

[36]             'OECD TG' refers to OECD Test Guidelines.

[37]             'UNION TM' refers to methods included in Commission
Regulation (EC) 440/2008.

[38]             Working Group of National
Coordinators of the OECD Test Guideline Programme.